1. Field of the Invention
The present invention relates generally to the field of transtracheal catheters. More specifically, the present invention discloses a surgical method for inserting a transtracheal catheter into the trachea of a patient.
2. Statement of the Problem
Various types of transtracheal catheters have been widely used in the medical field for many years to provide oxygen therapy to cardiac and pulmonary patients. The most common method for inserting a transtracheal catheter is known as the modified Seldinger technique. Under local anesthesia, a hypodermic needle is passed through the anterior neck into the trachea. A guide wire is inserted through the needle into the trachea. The needle is then removed, leaving the guide wire in place. The size of the opening is progressively increased by inserting a dilator and then a non-functioning stent over the guide wire. The stent generally remains in place for at least one week to allow a degree of healing of the resulting tract. The stent is then withdrawn over the guide wire, a transtracheal catheter is inserted into the trachea, and transtracheal oxygen therapy is commenced.
Although the modified Seldinger technique is relatively simple, complications such as subcutaneous emphysema and pneumothorax have been known to occur. Few pulmonologists perform the procedure with sufficient frequency to obtain a high level of comfort and proficiency. In addition, this technique generally takes six to eight weeks for the tract to mature sufficiently to allow daily catheter changes and cleaning by the patient. Mucus balls can accumulate at the catheter tip during this period, which can lead to potentially dangerous episodes of upper airway obstruction. This is also the period when inadvertent catheter dislodgement is most likely to occur. Although transtracheal oxygen therapy can be administered through an immature tract, this requires a detailed and laborious protocol for tract maintenance and catheter cleaning that cannot typically be done by the patient without professional assistance. These concerns mandate that out-of-town patients must remain relatively close to a major medical center during this period.
Once the tract matures, there is still a significant incidence of tract-related complications. Tract granulations and keloids can lead to pain and bleeding. Approximately 7% to 15% of patients develop tracheal chondritis, which may become a chronic problem. Inadvertent catheter dislodgement can occur even with a mature tract, and occurs in about 22% to 35% of all patients on transtracheal oxygen therapy at some point. This leads to an emergency office or hospital visit for reinsertion, which can be both uncomfortable and painful. Complete closure of the epithelial tract occurs in about 7% to 10% of patients.
The following are other examples of the prior art relating to procedures or devices for inserting transtracheal catheters or performing tracheostomies:
______________________________________ Inventor Patent No. Issue Date ______________________________________ Violet 3,307,551 March 7, 1967 Pollard 4,608,982 Sept. 2, 1986 Melker 4,677,978 July 7, 1987 Schachner et al. 4,889,112 Dec. 26, 1989 Spofford et al. 5,186,168 Feb. 16, 1993 Griggs 5,279,285 Jan. 18, 1994 Beck et al. 5,339,809 Aug. 23, 1994 ______________________________________
Violet discloses an emergency tracheostomy kit that includes both a scalpel blade 16 and a tubular airway 18 that can be inserted into the incision.
Pollard discloses a surgical forceps for use in association with a catheter. The catheter can be used, for example, to puncture the wall of the trachea. Pollard also mentions that a conventional procedure is to excise the overlaying layers of skin and fat and then puncture the exposed muscle layer to reach the trachea. One example is shown in FIGS. 4 and 5 of the Pollard patent for the pleural cavity 30 instead of the trachea.
Melker discloses a system for performing emergency cricothyrotomy ventilation. A scalpel 12 is used to make the initial incision between the thyroid and cricoid cartilage.
Schachner et al. disclose an apparatus for performing a tracheostomy operation. The trachea is initially penetrated using a syringe needle. A guide wire is then inserted through the small opening in the trachea. The instrument (T) is inserted into the opening while being guided by the wire. The instrument is opened after insertion to widen the trachea opening and allow subsequent insertion of a cannula.
Spofford et al. disclose a transtracheal catheter system. This patent discloses a method of insertion using a hypodermic needle to initially insert a guide wire into the trachea. A dilator is then inserted over the guide wire to form a tract. A temporary stent is used to maintain the opening during an initial healing period before the transtracheal catheter is inserted.
Griggs discloses another example of a method and apparatus for inserting a tracheostomy tube into the trachea of a patient. Here again, a hollow needle is used to make the initial opening into the trachea.
Beck et al. disclose another method for providing oxygen therapy using a cricothyroidal endotracheal device.
3. Solution to the Problem
None of the prior art references use the present surgical procedure of creating skin flaps at the edges of the incision, removing subcutaneous fat, and suturing the flaps to the sternothyroid muscle to create a saucerized tract for insertion of a transtracheal catheter. In addition, none of the prior art references combine the present surgical technique with use of a tracheostomy tube as a stent during initial healing of the tract.